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Completed

NCT Number: NCT01881893

Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial

The psychosocial development of adults with congenital heart disease (CHD) can be challenged by many issues including family overprotection, impaired peer relationships, delayed progression into independent adulthood, and difficulties with career and future planning. One-third of patients have diagnosable mood or anxiety disorders and the prevalence of depression is 3 times that of the general Canadian population. Unfortunately, most adults with CHD and significant depression or anxiety do not receive mental health treatment. Despite an increasing awareness of the unique psychosocial concerns of this patient population by both health care providers and patients, there have been no interventions targeting psychosocial outcomes in the adult CHD population. Our quantitative and qualitative research suggests that patients themselves are very interested in psychological services that target their distinctive life experiences, are provided in a group setting, and emphasize coping and resilience. The overarching aim of this proposal is to assess the feasibility of a full-scale randomized controlled trial of a group intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with CHD.

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Key information

Conditions

Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Congenital Cardiac Clinic for Adults, Peter Munk Cardiac Centre, Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented congenital heart disease (CHD), as confirmed by echocardiogram, cardiac catheterization, or previous surgery
  • Age greater than or equal to 18 years
  • English-language proficiency sufficient to read and complete the consent form and questionnaires and participate in an English-language group
  • No planned surgery during patient's participation in the study
  • Clinically-elevated score (i.e >=8) on the Hospital Anxiety and Depression Scale depression (HADS-D) or anxiety (HADS-A) subscale

Exclusion criteria

  • Current psychotherapy or pharmacotherapy
  • Significant cognitive impairment, psychosis, or personality disorder as documented in medical chart
  • Report of suicidal intent during screening

Treatment and study plan

ACHD-CARE Program

Behavioral

The ACHD-CARE program will be provided in eight 90-minute weekly sessions. The intervention includes information about living with congenital heart disease, cognitive behavioral therapy (CBT) and coping techniques, and opportunities for peer interaction.

Primary outcomes

  1. Psychosocial Outcome Measures: Change in depression and anxiety symptoms

    Time frame: Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up

    Symptoms of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS)

Secondary outcomes

  1. Psychological Outcome Measures: Social functioning

    Time frame: Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up

    Two metrics will be used to assess social functioning; the Social Functioning subscale of the Short Form Health Status Survey (SF-12v2) and the Enhanced Recovery in Coronary Heart Disease (ENRICHD) Social Support Inventory (ESSI).

  2. Psychosocial Outcome Measures: Resilience

    Time frame: Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up

    This psychosocial outcome will be measured by the Resilience Scale (RS).

  3. Psychosocial Outcome Measures: Quality of Life and health status

    Time frame: Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up

    The quality of life of the participants will be measured using the Satisfaction with Life Scales (SWLS) and the Linear Analogue Scale (LAS). Health status will be assessed using the SF-12v2.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: ACHD-CARE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 20, 2013
Registry last updated
Dec 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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